General Information

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the act) established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective. The most regulated devices are in Class III. The amendments define a Class III device as one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury . Insufficient information exists on a Class III device so that performance standards (Class II) or general controls (Class I) cannot provide reasonable assurance that the device is safe and effective for its intended use. Under Section 515 of the act, all devices placed into Class III are subject to premarket approval requirements. Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices.

An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the act and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional Class III devices.

A preamendments device is one that was in commercial distribution before May 28, 1976, the enactment date of the Medical Device Amendments. Manufacturers of Class III preamendments devices are not required to submit a PMA until 30 months after the promulgation of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later. FDA may allow more than 90 days after promulgation of a final rule for submission of a PMA.

A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices that FDA determines are substantially equivalent to preamendments Class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with Section 510(k) of the act. Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into Class I or II are "new" devices and fall automatically into Class III. Before such devices can be marketed, they must have an approved premarket approval application or be reclassified into Class I (general controls) or Class II (standards).

Class III transitional devices and "new" devices (described in the paragraph above) are automatically classified into Class III by statute and require premarket approval by FDA before they may be commercially distributed. Applicants may either submit a PMA or Product Development Protocol (PDP), or they may petition FDA to reclassify the devices into Class I or Class II. Clinical studies in support of a PMA, PDP, or a reclassification petition are subject to the investigational device exemption (IDE) regulations. (For further details on these regulations, refer to 21 CFR 812 for general devices or 21 CFR 813 for intraocular lenses.)

New section 515 (d)(6) of the act added by the FDA Modernization Act of 1997, provides that PMA supplements are required for all changes that affect safety and effectiveness unless such change involves modifications to manufacturing procedures or method of manufacture. These types of manufacturing changes require a 30-day Notice or, where FDA finds such notice inadequate, a 135-day PMA supplement.

Requesting Administrative Review of CDRH's Decision to Approve a Premarket Approval (PMA) Application or a Notice of Completion for a Product Development Protocol *

As of January 30, 1998, FDA discontinued publication of individual PMA approvals in the Federal Register (Final Rule in Federal Register Vol 63 No. 20, Friday January 30, 1998, pg 4571). Instead, FDA will notify the public of its decision to approve a PMA by making available, via FDA's Devices Approved page, a summary of the safety and effectiveness data upon which the approval is based. Written requests for this information can also be made to the Dockets Management Branch at the addressed identified below.

The 30-day period to submit petitions for administrative review will begin on the day the summary information is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Petitioners may, at any time on or before the 30th day, file with the Dockets Management Branch two copies of each petition and supporting data and information, identified with the name of the device and appropriate docket number. Petitions for administrative review must be submitted to:

Received petitions may be seen in the office above between 9 a.m. and 4p.m., Monday through Friday.

Section 515(d)(4) of the act authorizes any interested person to petition, under section 515(g) of the act, for administrative review of CDRH's decision to approve a PMA application. A petitioner may request either a formal hearing under 21 CFR part 12 of FDA's administrative practices and procedures regulations or a review of the application and CDRH's action by an independent advisory committee of experts. A petition is to be in the form of a petition for reconsideration under 21 CFR 10.33(b). A petitioner shall identify the form of review requested (hearing or independent advisory committee) and shall submit with the petition supporting data and information showing that there is a genuine and substantial issue of material fact for resolution through administrative review. After reviewing the petition, FDA will decide whether to grant or deny the petition and will publish a notice of its decision in the Federal Register. If FDA grants the petition, the notice will state the issue to be reviewed, the form of the review to be used, the persons who may participate in the review, the time and place where the review will occur, and other details.

* Under 21 CFR 814.19 a class III device for which a PDP has been declared completed by FDA is considered to have an approved PMA.

Searching The Releasable PMA Database

The PMA database may be searched by a variety of fields. A search query will produce information from the database in the following format:

Classification Name

Generic Name

Applicant

PMA Number

Supplement Number

Trade Name

Date Received

Decision Date

Product Code

Advisory Committee

Supplement Type

Supplement Reason

Expedited Review Granted (Y/N)

Approval Order Statement

PMA/PDP Files for Downloading

You can download the following zipped file, pma.zip, which contains information about the releasable PMA's. These files are replaced monthly usually on the 5th of each month. In addition there is a file description and an explanation of some of the codes used in the file.You can also download or search the Product Code Classification Database which contains medical device names and associated information.

Monthly PMA Listings (in standard text format)

The monthly listing contains information regarding decisions for PMAs, PDPs, Supplements, and Notices. The date of the decision and application information such as address, device trade name, indication (in the case of an original or panel track supplement approval) or the nature of the change are provided. In addition, a table of summary statistics are provided for the numbers of submissions and review times.